PreDiabetesNCT03332927
Effect of Egg Consumption on Cardiometabolic Health in Prediabetic Subjects.
A study testing Egg based breakfast foods and Non-egg based breakfast foods in people with PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The objective of this trial is to assess the effects of whole egg consumption (12 per week), compared to energy-matched typical breakfast control foods, on insulin sensitivity and other markers of metabolic health, including fasting lipoprotein lipid levels and resting blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Egg based breakfast foods and Non-egg based breakfast foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2017to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI of ≥25.0 kg/m2 (≥23.0 kg/m2 in Asian Americans) to 39.99 kg/m2.
- Metabolic syndrome [exhibiting at least 3 out of 5 of these criteria]: waist circumference ≥102 cm (40 inches) in men or ≥88 cm (35 inches) in women, TG level ≥150 mg/dL, HDL-C level <40 mg/dL in men or <50 mg/dL in women, hypertension: ≥130 systolic and/or /≥85 diastolic or on drug therapy for elevated BP, fasting hyperglycemia: 100-125 mg/dL.
- Prediabetes [exhibiting any of the criteria below at screening]: glycated hemoglobin 5.7-6.4% (inclusive), or fasting capillary glucose of 100-125 mg/dL (inclusive), or a 2-h postprandial glucose of 140-199 mg/dL.
Who cannot join
- Atherosclerotic cardiovascular disease including any of the following:
- clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound] or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type 1 or 2 diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, neurologic, or biliary disorders.
- Known allergy, sensitivity, or intolerance to any ingredients in the study foods.
- Uncontrolled hypertension
- Recent history of cancer in the prior 5 years, except for non-melanoma skin cancer.
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- Recent change in body weight of ±4.5 kg.
- Unstable use of any antihypertensive medication.
- Recent use of any medications intended to alter the lipid profile [e.g. bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, and/or proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors], weight-loss drugs, systemic corticosteroid drugs, medications known to influence carbohydrate (CHO) metabolism [e.g. adrenergic receptor blockers, thiazide diuretics, hypoglycemic medications], and/or anti-psychotics.
- Recent use of foods or dietary supplements that might influence lipid metabolism [e.g. omega-3 fatty acid supplements (e.g., fish or algal oils) or fortified foods, sterol/stanol products; dietary supplements (red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >400 mg/d], inconsistent use of Metamucil® or viscous fiber-containing supplements
- Use of antibiotics within 5 days of screening.
- Pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Extreme dietary habits (e.g., vegan or very low carbohydrate diet).
- Current or recent history or strong potential, for drug or alcohol abuse.
- History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
- Recent exposure to any non-registered drug product.
Trial locations and contacts
1 site in 1 country.
United States1 site
Great Lakes Clinical Trials
Chicago, Illinois, 60640
About this study
Official title: A Randomized, Crossover Trial to Assess the Effects of Replacing Commonly Consumed Breakfast Foods With Eggs on Insulin Sensitivity and Other Markers of Cardiometabolic Health in Men and Women at Increased Risk for Type 2 Diabetes Mellitus.
The objective of this trial is to assess the effects of whole egg consumption (12 per week), compared to energy-matched typical breakfast control foods, on insulin sensitivity and other markers of metabolic health, including fasting lipoprotein lipid levels and resting blood pressure.
Read the detailed description
This is a randomized, crossover study that includes two screening visits and two 4-week test periods separated by a 4-week washout. Subjects will consume two eggs/day (12 eggs/week consumed over 6 days per week, provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet) or non-egg based control foods (provided as breakfast foods such as English muffins, bagels, ready-to-eat cereal, and flavored muffins). The background diet will be a habitual diet. The nutritional profiles of the egg and control breakfast foods will be designed such that the energy from eggs will be substituted for a mixture of carbohydrate, protein and fat in the control foods.
Study foods will be dispensed with instructions to consume the assigned breakfast food starting on day 1. Subjects will be instructed to consume the breakfast foods in their entirety each day, for the duration of the 28 day test period, and to record daily study food intake. Subjects will receive diet instruction on the incorporation of food substitutions during the test period to maintain habitual energy intake. Compliance will be assessed using the Daily Log intake and number of foods consumed based on returned foods.
An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period for evaluation of insulin sensitivity. Blood will be collected for a fasting lipid profile (at all visits), glucose and insulin, high-sensitivity C-reactive protein (hs-CRP), vertical auto profile (VAP) for cholesterol carried by lipoprotein fractions (at baseline and end of each treatment period), with additional blood samples collected for storage and archived for possible future analysis of non-genetic indicators of metabolism. Assessments of vital signs and body weight, review of concomitant medication/supplement use and inclusion and exclusion criteria for relevant changes, and evaluation of adverse effects will be performed throughout the study.
- Conditions
- PreDiabetes
- Being tested
- Egg based breakfast foods, Non-egg based breakfast foods
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg based breakfast foodsOther
Two eggs/day, 6 days per week provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet.
Non-egg based breakfast foodsOther
Non-egg based control foods provided as breakfast foods 6 days per week such as waffles, ready-to-eat cereal, fruits and cheeses.
| Study group | Role | What they receive |
|---|---|---|
| Egg based breakfast foods | Experimental | Study products delivering two eggs/day, 6 days per week, will be administered for the 4-week treatment period. Receives: Other: Egg based breakfast foods |
| Non-egg based breakfast foods | Active comparator | Study products delivering non-egg based control breakfast foods will be administered 6 days per week for the 4-week treatment period. Receives: Other: Non-egg based breakfast foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity index (IV-SI) from short (40 min) IVGTT.
Percent change or change from baseline to end of each treatment condition
Measured: Up to 40 minutes - measured at baseline and end of each treatment period.
Secondary outcomes (12)
Disposition index [acute insulin response to intravenous glucose (AIRg) x IV-SI]
Percent change (or change) from baseline to the end of each treatment period.
Measured: Up to 40 minutes - measured at baseline and end of each treatment period.
Glucose fractional disappearance rate from t = 10-40 min (Kg)
Percent change (or change) from baseline to the end of each treatment period.
Measured: Up to 40 minutes - measured at baseline and end of each treatment period.
Homeostasis model assessments of insulin sensitivity (HOMA%S)
Percent change (or change) from baseline to the end of each treatment period.
Measured: Up to 29 days for each treatment period
Beta-cell function (HOMA%B)
Percent change (or change) from baseline to the end of each treatment period.
Measured: Up to 29 days for each treatment period
Percent change in Total cholesterol (TC)
Percent change in TC from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Measured: Up to 29 days for each treatment period
Percent change in low-density lipoprotein cholesterol (LDL-C)
Percent change in LDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Measured: Up to 29 days for each treatment period
Percent change in high-density lipoprotein cholesterol (HDL-C)
Percent change in HDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Measured: Up to 29 days for each treatment period
Percent change in non-HDL-C
Percent change in non-HDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Measured: Up to 29 days for each treatment period
Percent change in TC/HDL-C ratio
Percent change in TC/HDL-C ratio from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Measured: Up to 29 days for each treatment period
Percent change in Triglycerides (TG)
Percent change in TG from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Measured: Up to 29 days for each treatment period
Seated, resting systolic and diastolic blood pressure (BP)
Percent change in seated, resting systolic and diastolic BP (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Measured: Up to 29 days for each treatment period
Vertical Auto-Profile (VAP) analysis of cholesterol carried by lipoproteins and lipoprotein subfractions.
Percent change in VAP analysed cholesterol in lipoproteins and lipoprotein subfractions from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Measured: Up to 29 days for each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start25 Oct 2017
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332927
- Sponsor's protocol ID
- MB-1704
- Status last verified
- Jul 2019
- First submitted
- 2 Nov 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Trial to Assess the Effects of Replacing Commonly Consumed Breakfast Foods With Eggs on Insulin Sensitivity and Other Markers of Cardiometabolic Health in Men and Women at Increased Risk for Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT03332927
- Acronym / sponsor ID
- MB-1704
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to assess the effects of whole egg consumption (12 per week), compared to energy-matched typical breakfast control foods, on insulin sensitivity and other markers of metabolic health, including fasting lipoprotein lipid levels and resting blood pressure.
Detailed description
This is a randomized, crossover study that includes two screening visits and two 4-week test periods separated by a 4-week washout. Subjects will consume two eggs/day (12 eggs/week consumed over 6 days per week, provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet) or non-egg based control foods (provided as breakfast foods such as English muffins, bagels, ready-to-eat cereal, and flavored muffins). The background diet will be a habitual diet. The nutritional profiles of the egg and control breakfast foods will be designed such that the energy from eggs will be substituted for a mixture of carbohydrate, protein and fat in the control foods.
Study foods will be dispensed with instructions to consume the assigned breakfast food starting on day 1. Subjects will be instructed to consume the breakfast foods in their entirety each day, for the duration of the 28 day test period, and to record daily study food intake. Subjects will receive diet instruction on the incorporation of food substitutions during the test period to maintain habitual energy intake. Compliance will be assessed using the Daily Log intake and number of foods consumed based on returned foods.
An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period for evaluation of insulin sensitivity. Blood will be collected for a fasting lipid profile (at all visits), glucose and insulin, high-sensitivity C-reactive protein (hs-CRP), vertical auto profile (VAP) for cholesterol carried by lipoprotein fractions (at baseline and end of each treatment period), with additional blood samples collected for storage and archived for possible future analysis of non-genetic indicators of metabolism. Assessments of vital signs and body weight, review of concomitant medication/supplement use and inclusion and exclusion criteria for relevant changes, and evaluation of adverse effects will be performed throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egg based breakfast foods | Experimental | Other: Egg based breakfast foodsStudy products delivering two eggs/day, 6 days per week, will be administered for the 4-week treatment period. |
| Non-egg based breakfast foods | Active comparator | Other: Non-egg based breakfast foodsStudy products delivering non-egg based control breakfast foods will be administered 6 days per week for the 4-week treatment period. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI of ≥25.0 kg/m2 (≥23.0 kg/m2 in Asian Americans) to 39.99 kg/m2.
- Metabolic syndrome [exhibiting at least 3 out of 5 of these criteria]: waist circumference ≥102 cm (40 inches) in men or ≥88 cm (35 inches) in women, TG level ≥150 mg/dL, HDL-C level <40 mg/dL in men or <50 mg/dL in women, hypertension: ≥130 systolic and/or /≥85 diastolic or on drug therapy for elevated BP, fasting hyperglycemia: 100-125 mg/dL.
- Prediabetes [exhibiting any of the criteria below at screening]: glycated hemoglobin 5.7-6.4% (inclusive), or fasting capillary glucose of 100-125 mg/dL (inclusive), or a 2-h postprandial glucose of 140-199 mg/dL.
Key exclusion criteria (16 listed)
- Atherosclerotic cardiovascular disease including any of the following:
- clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound] or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type 1 or 2 diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, neurologic, or biliary disorders.
- Known allergy, sensitivity, or intolerance to any ingredients in the study foods.
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg based breakfast foodsTwo eggs/day, 6 days per week provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet. | Other | Egg based breakfast foods |
| Non-egg based breakfast foodsNon-egg based control foods provided as breakfast foods 6 days per week such as waffles, ready-to-eat cereal, fruits and cheeses. | Other | Non-egg based breakfast foods |
Primary outcome
Insulin sensitivity index (IV-SI) from short (40 min) IVGTT.
Time frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Percent change or change from baseline to end of each treatment condition
12 secondary outcomes
Disposition index [acute insulin response to intravenous glucose (AIRg) x IV-SI]
Time frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Glucose fractional disappearance rate from t = 10-40 min (Kg)
Time frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Homeostasis model assessments of insulin sensitivity (HOMA%S)
Time frame: Up to 29 days for each treatment period
Beta-cell function (HOMA%B)
Time frame: Up to 29 days for each treatment period
Percent change in Total cholesterol (TC)
Time frame: Up to 29 days for each treatment period
Percent change in low-density lipoprotein cholesterol (LDL-C)
Time frame: Up to 29 days for each treatment period
Percent change in high-density lipoprotein cholesterol (HDL-C)
Time frame: Up to 29 days for each treatment period
Percent change in non-HDL-C
Time frame: Up to 29 days for each treatment period
Percent change in TC/HDL-C ratio
Time frame: Up to 29 days for each treatment period
Percent change in Triglycerides (TG)
Time frame: Up to 29 days for each treatment period
Seated, resting systolic and diastolic blood pressure (BP)
Time frame: Up to 29 days for each treatment period
Vertical Auto-Profile (VAP) analysis of cholesterol carried by lipoproteins and lipoprotein subfractions.
Time frame: Up to 29 days for each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg based breakfast foods and Non-egg based breakfast foods in people with PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity index (IV-SI) from short (40 min) IVGTT. (time frame: Up to 40 minutes - measured at baseline and end of each treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.